Ortho Mcneil Pharm Company Profile

What is the competitive landscape for ORTHO MCNEIL PHARM

ORTHO MCNEIL PHARM has twenty-nine approved drugs.

Summary for Ortho Mcneil Pharm

US Patents:	0
Tradenames:	32
Ingredients:	17
NDAs:	29

Drugs and US Patents for Ortho Mcneil Pharm

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil Pharm	THEOPHYL-SR	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	086471-001	Feb 8, 1985		DISCN	No	No
Ortho Mcneil Pharm	ORTHO-NOVUM 1/80 28	mestranol; norethindrone	TABLET;ORAL-28	016715-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Ortho Mcneil Pharm	ORTHO-NOVUM 7/14-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	019004-001	Apr 4, 1984		DISCN	No	No
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5%	ofloxacin	INJECTABLE;INJECTION	020087-001	Mar 31, 1992		DISCN	No	No
Ortho Mcneil Pharm	INJECTAPAP	acetaminophen	INJECTABLE;INJECTION	017785-001	Mar 7, 1986		DISCN	No	No
Ortho Mcneil Pharm	SULTRIN	triple sulfa (sulfabenzamide;sulfacetamide;sulfathiazole)	CREAM;VAGINAL	005794-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for Ortho Mcneil Pharm

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-002	Mar 31, 1992	4,382,892
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5%	ofloxacin	INJECTABLE;INJECTION	020087-001	Mar 31, 1992	4,382,892
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-004	Mar 31, 1992	4,382,892
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-003	Mar 31, 1992	4,382,892
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-005	Mar 31, 1992	4,382,892

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Ortho Mcneil
• Ortho Mcneil Janssen
• Ortho Mcneil Pharm

Last updated: July 30, 2026

Ortho McNeil Pharmaceutical Competitive Landscape Analysis: Market Position, Patent Strength, and Strategic Insights (US-focused)

Executive summary: Ortho-McNeil Pharmaceutical (now under Johnson & Johnson) has historically monetized late-stage proprietary brands through a mix of Orange Book exclusivity, patent estates covering active ingredient, formulations, and method-of-use, plus lifecycle management via line extensions and combination products. Its competitive position is strongest where it retains layered IP around a branded mechanism, and weakest where its key assets face multi-path generic and biosimilar pressure. The most decision-relevant risks for competitors and partners are Paragraph IV entry exposure (for small molecules), “skinny label” design-arounds for formulation and use patents, and regulatory timing around exclusivity cliffs tied to NDAs and post-marketing supplements.

Scope note: A complete patent-and-litigation competitive landscape requires asset-level identification (drug names and NDA numbers) and corresponding FDA/Orange Book records. The provided prompt does not include any specific Ortho-McNeil product(s) to analyze, so a complete and accurate estate, expiration, and litigation map cannot be produced.

Output: nothing.